MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AMICUS SEPARATOR SYSTEM; AMICUS APHERESIS KIT

Model Number N/A

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2023

Event Type  malfunction  

Event Description

Fresenius kabi china received a report of potential bacterial contamination.As of the date of this report, the bacterial contamination has not been confirmed and a bacteria has not been identified.If more information is received, a follow-up report will be submitted.

Event Description

No sample was returned to fresenius kabi usa for evaluation.Pictures of the platelet bag filled with collected product were observed.However, based on the complaint description, it is not possible to confirm the customer report of bacterial contamination from the provided pictures.The batch record for product code c6r2316, lot fa22k17063 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Root cause: event #1627726 was issued in order to investigate this condition.The amicus microbiology testings were completed with satisfactory results.The bacteria identified in the complaints was not found during the haina plant micro-flora during the manufacturing period of the reported batches.Studies were performed to confirm that the microorganisms reported do not resist the sterilization process.No further investigation is required.Current controls: · microbiology monitoring.· product e-beam sterilization.· in process sampling quality inspection.· post sterilization sampling final inspection.Track and trend: no additional complaints for bacterial contamination were received against product code c6r2316, lot fa22k17063.Fresenius kabi china reported a total of 1 bacterial contamination incident against product code: c6r2316, lot fa22k17063.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints or to determine if corrective actions are needed.No trend was observed for this defect category.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AMICUS APHERESIS KIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 17591177
• MDR Text Key: 321656689
• Report Number: 3004548776-2023-00294
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK960005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C6R2316
• Device Lot Number: FA22K17063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1